AAMI - TIR76
Sterilization of health care products—Radiation— Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VDmax SD-S
active, Most Current
| Organization: | AAMI |
| Publication Date: | 1 January 2021 |
| Status: | active |
| Page Count: | 48 |
scope:
Inclusions
This document describes a method for substantiating a selected sterilization dose that achieves maximally a selected sterility assurance level (SAL) for radiation sterilization of healthcare products. This document also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.
NOTE Selection and substantiation of the sterilization dose is used to meet the requirements for establishing the sterilization dose within process definition in ANSI/AAMI/ISO 11137-1.
Application
If the decision is made to use this method of sterilization dose establishment, the method is to be followed according to the requirements (shall) and guidance (should) stipulated herein.
Document History
TIR76
January 1, 2021
Sterilization of health care products—Radiation— Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VDmax SD-S
Inclusions
This document describes a method for substantiating a selected sterilization dose that achieves maximally a selected sterility assurance level (SAL) for radiation sterilization of...